Arthritis, RheumatoidGO FARNCT03729349
Golimumab for Adherence in Rheumatoid Arthritis
An observational study of Arthritis, Rheumatoid, run by Janssen Inc. at 32 sites in Canada.
Trial summary
The purpose of this study is to determine if non-adherence to Rheumatoid Arthritis (RA) drugs in participants treated with biologic disease modifying anti-rheumatic drugs (DMARDs) is associated with a greater incidence of disease in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Golimumab
- How many people
- 222 participants
- Where
- 32 sitesCanada
- Study dates
- 15 Jan 2019to 19 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed.
Who may be able to join
- Must have a confirmed diagnosis of rheumatoid arthritis
- About to initiate therapy with golimumab
- Must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
Who cannot join
- Diagnosis of Axial Spondyloarthritis, Ankylosing Spondylitis or Psoriatic Arthritis
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point
- Currently enrolled in an investigational study
- Currently enrolled in an observational study sponsored or managed by a Janssen company
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Canada32 sites
The Waterside Clinic
Barrie, Ontario, L4M 6L2
Dr. Sankalp V. Bhavsar Medicine Professional Corporation
Burlington, Ontario, L7R 2H3
Peak Medical Specialty Centre
Calgary, Alberta, T3B 0B2
Private Practice - Dr. Pauline Boulos
Dundas, Ontario, L9H 1B7
Dr. Sangeetha Thiviyarajah Medicine Professional Corporation
Etobicoke, Ontario, M9V 3Z7
Samuel Silverberg Medicine Professional Corporation
Etobicoke, Ontario, M9V 5G5
Fredericton Medical Clinic
Fredericton, New Brunswick, E3B 6H5
Adachi Medicine Professional Corporation
Hamilton, Ontario, L8N 1Y2
Manisha Mulgund Medicine Professional Corporation
Hamilton, Ontario, L9C 5N2
K-W Musculoskeletal Research Inc
Kitchener, Ontario, N2M 5N6
Private Practice - Dr. Diane Wilson
Lunenburg, Nova Scotia, B0J2C0
Markham Rheumatology Hub
Markham, Ontario, L3R 2C7
Credit Valley Rheumatology
Mississauga, Ontario, L5M 2V8
Clinique de Rhumatologie de Montreal
Montreal, Quebec, H4N 1C6
Dr. Rajwinder S Dhillon Medicine Professional Corporation
Niagara Falls, Ontario, L2E 6A6
Makhzoum Medicine Professional Coporation
Oakville, Ontario, L6H 3P1
Dr. S. Gill Medicine Professional Corporation
Oakville, Ontario, L6M 1M1
Jacqueline C Stewart Medical Inc.
Penticton, British Columbia, V2A 3G7
Private Practice Dr Louis Bessette
Québec, Quebec, G1V 3M7
Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
Rimouski, Quebec, G5L 5T1
Community Rheumatology Care
Saskatoon, Saskatchewan, S7K 0H6
Rheumatology Associates of Saskatoon
Saskatoon, Saskatchewan, S7K 0H6
CIUSSS de L Estrie CHUS
Sherbrooke, Quebec, J1G 2E8
Clinique Jacques Cartier- Rheumatology Division - Université de Sherbrooke
Sherbrooke, Quebec, J1J 2E3
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8
St Clare's Hospital
St. John's, Newfoundland and Labrador, A1C 2E9
Dr. Abraham Chaiton Medicine Professional Corporation
Toronto, Ontario, M3N 2V6
Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Arthur Karasik Medicine Professional Corporation
Toronto, Ontario, M6C 1Y8
Centre de Recherche Musculo Squelettique
Trois-Rivières, Quebec, G8Z1Y2
Dr. Milton F Baker Inc.
Victoria, British Columbia, V8P 5P6
Dr. Sabeen Anwar Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
About this study
The purpose of this study is to determine if non-adherence to Rheumatoid Arthritis (RA) drugs in participants treated with biologic disease modifying anti-rheumatic drugs (DMARDs) is associated with a greater incidence of disease in clinical practice.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Golimumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolimumabBiological
Also called SIMPONI ™
Participants will receive golimumab as a part of clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Diagnosis of Rheumatoid Arthritis | Participants will not receive any intervention as a part of this study. All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed. Receives: Biological: Golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Adherence on Flares as Assessed by Rheumatoid Arthritis Flare Questionnaire (RA-FQ) Score at 6 Month
Impact of adherence on flares will be assessed by RA-FQ score or the answer to question 7 of the RA-FQ (Are you having a flare?) at 6 month in participants categorized as "low predicted compliance" vs "high predicted compliance". RA-FQ is 10 point scale for questions 1 to 5, with score range from 0 to 10, where higher score indicates worse outcome and having option 'Yes' and 'No' for question 6 and 7. The RA-FQ total score is calculated as the sum of responses for items 1-5 (maximum 50). Higher score indicates worst outcome.
Measured: 6 Month
Impact of Adherence on Flares as Assessed by RA-FQ Score at 12 Month
Impact of adherence on flares will be assessed by RA-FQ score or the answer to question 7 of the RA-FQ (Are you having a flare?) at 12 month in participants categorized as "low predicted compliance" vs "high predicted compliance". RA-FQ is 10 point scale for questions 1 to 5, with score range from 0 to 10, where higher score indicates worse outcome and having option 'Yes' and 'No' for question 6 and 7. The RA-FQ total score is calculated as the sum of responses for items 1-5 (maximum 50). Higher score indicates worst outcome.
Measured: 12 Month
Secondary outcomes (5)
Percentage of Adherent Participants at 6 and 12 Months
Percentage of adherent participants at 6 and 12 Months will be assessed.
Measured: Months 6 and 12
Number of Participants with Corticosteroid Use
Number of participants with corticosteroid use will be assessed among participants categorized as "low predicted compliance" vs "high predicted compliance" at 6 and 12 months.
Measured: Months 6 and 12
Predicting Factors for Adherence
Independent predictors of "predicted compliance" will be assessed with univariate and multivariate Cox regression analysis.
Measured: Months 6 and 12
Number of Participants with any Adverse Events (AEs), Serious Adverse Events (SAEs) or Discontinuation of Golimumab
Number of participants with any AEs, SAEs or discontinuation of golimumab will be assessed among participants categorized as "low predicted compliance" vs "high predicted compliance" at 6 and 12 months and include any such event up to the previous study visit.
Measured: Months 6 and 12
Percentage of Participants with Response to Patient Support Program Question
Percentage of participants with response to Patient Support Program Question (Yes/No) will be assessed among participants categorized as "low predicted compliance" vs "high predicted compliance" at 6 and 12 months.
Measured: Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start15 Jan 2019
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Inc. Clinical Trial, Study director, Janssen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729349
- Sponsor's protocol ID
- CR108555
- Other IDs
- CNTO148ARA4010
- Acronym
- GO FAR
- Status last verified
- Jul 2024
- First submitted
- 1 Nov 2018
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bessette L, Boulos P, Arendse R, Rahman P, Aseer S, Ruban T, Rachich M, Nantel F, Calce A, Asin-Milan O, Haaland D. Impact of Adherence to Golimumab on Disease Flares in Rheumatoid Arthritis: Results from a Canadian Observational Study. Patient Prefer Adherence. 2025 Jun 25;19:1843-1853. doi: 10.2147/PPA.S516794. eCollection 2025.
PubMed 40585577
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Golimumab for Adherence in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03729349
- Acronym / sponsor ID
- GO FAR / CR108555
- Conditions
- Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Janssen Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if non-adherence to Rheumatoid Arthritis (RA) drugs in participants treated with biologic disease modifying anti-rheumatic drugs (DMARDs) is associated with a greater incidence of disease in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Diagnosis of Rheumatoid Arthritis | – | Biological: GolimumabParticipants will not receive any intervention as a part of this study. All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed.
Key inclusion criteria (3 listed)
- Must have a confirmed diagnosis of rheumatoid arthritis
- About to initiate therapy with golimumab
- Must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
Key exclusion criteria (4 listed)
- Diagnosis of Axial Spondyloarthritis, Ankylosing Spondylitis or Psoriatic Arthritis
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point
- Currently enrolled in an investigational study
- Currently enrolled in an observational study sponsored or managed by a Janssen company
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GolimumabAlso: SIMPONI ™Participants will receive golimumab as a part of clinical practice. | Biological | Participants with Diagnosis of Rheumatoid Arthritis |
Primary outcome
Impact of Adherence on Flares as Assessed by Rheumatoid Arthritis Flare Questionnaire (RA-FQ) Score at 6 Month
Time frame: 6 Month
Impact of adherence on flares will be assessed by RA-FQ score or the answer to question 7 of the RA-FQ (Are you having a flare?) at 6 month in participants categorized as "low predicted compliance" vs "high predicted compliance". RA-FQ is 10 point scale for questions 1 to 5, with score range from 0 to 10, where higher score indicates worse outcome and having option 'Yes' and 'No' for question 6 and 7. The RA-FQ total score is calculated as the sum of responses for items 1-5 (maximum 50). Higher score indicates worst outcome.
Impact of Adherence on Flares as Assessed by RA-FQ Score at 12 Month
Time frame: 12 Month
Impact of adherence on flares will be assessed by RA-FQ score or the answer to question 7 of the RA-FQ (Are you having a flare?) at 12 month in participants categorized as "low predicted compliance" vs "high predicted compliance". RA-FQ is 10 point scale for questions 1 to 5, with score range from 0 to 10, where higher score indicates worse outcome and having option 'Yes' and 'No' for question 6 and 7. The RA-FQ total score is calculated as the sum of responses for items 1-5 (maximum 50). Higher score indicates worst outcome.
5 secondary outcomes
Percentage of Adherent Participants at 6 and 12 Months
Time frame: Months 6 and 12
Number of Participants with Corticosteroid Use
Time frame: Months 6 and 12
Predicting Factors for Adherence
Time frame: Months 6 and 12
Number of Participants with any Adverse Events (AEs), Serious Adverse Events (SAEs) or Discontinuation of Golimumab
Time frame: Months 6 and 12
Percentage of Participants with Response to Patient Support Program Question
Time frame: Months 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Derived from this study: PubMed 40585577Bessette L, Boulos P, Arendse R, Rahman P, Aseer S, Ruban T, Rachich M, Nantel F, Calce A, Asin-Milan O, Haaland D. Impact of Adherence to Golimumab on Disease Flares in Rheumatoid Arthritis: Results from a Canadian Observational Study. Patient Prefer Adherence. 2025 Jun 25;19:1843-1853. doi: 10.2147/PPA.S516794. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Inc. Clinical Trial study director
Janssen Inc.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Janssen Inc. at 32 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Adherence on Flares as Assessed by Rheumatoid Arthritis Flare Questionnaire (RA-FQ) Score at 6 Month (time frame: 6 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03729349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.